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CompletedNCT03400891PROFRUVEUpdated Jan 17, 2018

PROFRUVE Program to Promote Fruit and Vegetables Intake Among Children.

An interventional study of Program based on the theory of planned behaviour in Eating Behavior, Healthy Diet and Fruit and Vegetable Intake, sponsored by University of the Basque Country (UPV/EHU). Completed. Open to participants aged 7 Years to 11 Years. Per ClinicalTrials.gov, last updated 2018-01-17.

Sponsored by University of the Basque Country (UPV/EHU) · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 2 years 7 months after the study started (first participant enrolled May 2015, registered Dec 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
230
Allocation
Randomized
Ages
7 Years to 11 Years
Sex
All
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Study summary

Because fruit and vegetables (FV) intake of children of Vitoria city is low, a controlled intervention program was proposed at school level. The intervention was based on the Theory of Planned Behavior (TPB) as long as behavioral theories have been proved to be the most effective changing infant FV intake pattern. The main purpose of the study is to evaluate the effectiveness of an intervention program based on TPB and aimed to increase FV consumption in schoolchildren aged 8 to 10. For that aim, eligible classrooms from different schools were randomly assigned to the intervention (n=86) or control (n=86) group. The intervention group received 14 sessions of 60 minutes during 9 months of an academic year. Sessions, designed by a multidisciplinary team, are based on TPB and aimed to modify determinants of behavior (attitudes, subjective norms, perceived behavioral control, intention of consumption), and intake of FV itself. Change in fruit and vegetable intake and determinants of eating behavior were evaluated at 9 months of intervention using validated surveys, 7 day food records, 24 hour reminders and questionnaires. This study will provide a valid and useful tool to achieve changes in the consumption of FV at school level. A negative result will be useful to help redefining new strategies in the framework of changing habits in the consumption of FV.

Read the detailed description

In Vitoria, only two out of ten children and adolescents (aged 6 to 17) consume the recommended three servings of fruit and only one out of ten the recommended two servings of vegetables per day. Average intake of fruit was 1.8 servings/day and 0.8 servings/day for vegetables. For that reason, promotion of the adequate intake of FV must be a priority objective in the promotion of healthy eating habits. One of the most used theories in this type of interventions is TPB (Theory of Planned Behavior). According to this theory, eating behavior and intention of consumption determinants are both personal and environmental. Specifically, the TPB states that attitude, subjective norms and perceived control are determinants that influence both the intention to consume food and the action of consuming it.

The hypothesis of the study is that an intervention program based on theories of behavior and aimed to increase FV intake in schoolchildren aged 8 to 10, will produce changes in attitude, subjective norms, perceived behavioral control and intention of eating fruit and vegetable among children, which in turn will modify the behavior, increasing FV intake.

The main objective of this study is to evaluate the effectiveness of an intervention program based on behavioral theory and aimed to increase FV intake in schoolchildren aged 8 to 10 (short and long effect).

Secondary objectives of the study are (i) to evaluate the change on FV intake on the study population after intervention, (ii) to examine the impact of the intervention program on behavioral determinants, (iii) to analyze the association of the determinants of behavior on FV intake, and (iv) to study the influence between social demographic variables and the effectiveness of the program.

The recruitment of participants begun in may 2015 and they were randomly assigned to intervention or control groups. The intervention group received 14 sessions (one every 15 days) of one hour to work TPB constructs: attitude; subjective norms; perceived behavioural control and intention.

02

Conditions studied

  • Eating Behavior
  • Healthy Diet
  • Fruit and Vegetable Intake
  • Childhood Obesity
03

In context

Feeding Behavior

985 studies on the registry are indexed under Feeding Behavior; 178 are open to participants now.

This study's enrollment of 230 is above the median of 77 across 700 interventional studies indexed under Feeding Behavior.

Browse Feeding Behavior studies →

Lead sponsor

University of the Basque Country (UPV/EHU) is the lead sponsor of 37 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years to 11 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • all schools with children aged 7-11 years old
  • schools with orchard

Exclusion criteria

Exclusion Criteria:

  • special schools
  • schools carrying out other healthy eating programs at the intervention period
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
230 participants (actual)

Study arms

  • Experimental
    Intervention

    This group received 14 sessions (one every 15 days) of one hour in the classroom, to work TPB constructs: attitude; subjective norms; perceived behavioural control and intention.

    Behavioral: Program based on the theory of planned behaviour

  • No intervention
    Control

    2 session of 1 hour each to give general information about fruit and vegetables intake and health.

Interventions

  • BehavioralProgram based on the theory of planned behaviour

    14 sessions of one hour to work TPB constructs: attitude, subjective norms, perceived behavioural control and intention.

06

What researchers measure

Primary outcomes

  1. FV intake

    Fruit and vegetable daily intake (servings/day)

    Time frame: Change from baseline food and vegetable intake at 9 months of intervention

Secondary outcomes

  1. Eating behaviour determinant: Attitude

    Evolution of attitude related to eat more FV (1-5 point score, from totally disagree to totally agree)

    Time frame: Change from baseline attitude at 9 months of intervention

  2. Eating behaviour determinant: Subjective Norms

    Evolution of subjective norms or social pressure related to eat more FV (1-5 point score, from totally disagree to totally agree)

    Time frame: Change from baseline subjective norms at 9 months of intervention

  3. Eating behaviour determinant: Perceived Behavioural Control

    Evolution of perceived behavioural control related to eat more FV (1-5 point score, from totally disagree to totally agree)

    Time frame: Change from baseline perceived behavioural control at 9 months of intervention

  4. Eating behaviour determinant: Intention

    Evolution of intention of eating more FV (1-5 point score, from totally disagree to totally agree)

    Time frame: Change from baseline intention at 9 months of intervention

  5. Social demographic outcomes

    Participants families social and demographic data

    Time frame: Change from baseline social demographic outcomes at 9 months of intervention

  6. Parents FV intake

    Parents fruits and vegetables daily intake (servings/day)

    Time frame: Change from parent's baseline food and vegetable intake at 9 months of interventions

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Arrizabalaga-Lopez M, Rada-Fernandez de Jauregui D, Portillo MDP, Mauleon JR, Martinez O, Etaio I, Tormo-Santamaria M, Bernabeu-Maestre J, Rodriguez VM. A theory-based randomized controlled trial in promoting fruit and vegetable intake among schoolchildren: PROFRUVE study. Eur J Nutr. 2020 Dec;59(8):3517-3526. doi: 10.1007/s00394-020-02185-5. Epub 2020 Feb 1. PubMed 32008063 ↗
  • Arrizabalaga-Lopez M, Rada-Fernandez de Jauregui D, Portillo MP, Martinez O, Etaio I, Mauleon JR, Echevarria E, Gomez F, Rodriguez VM. A randomised controlled trial of a program based on the theory of planned behavior to promote fruit and vegetable intake among schoolchildren: PROFRUVE study protocol. BMC Public Health. 2018 Jul 4;18(1):827. doi: 10.1186/s12889-018-5748-3. PubMed 29973190 ↗

Individual participant data

Plan to share: No — IPD will not be shared

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 17, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03400891
Lead sponsor
University of the Basque Country (UPV/EHU)
Responsible party
Victor Manuel Rodriguez Rivera (Doctor, University of the Basque Country (UPV/EHU)) — Principal investigator
First posted
Jan 17, 2018
Start date
May 11, 2015
Primary completion
Jun 16, 2017
Completion
Jun 16, 2017
Last update
Jan 17, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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